糖化血紅蛋白(HbA1c)標準化

HbA1c的檢測方法涉及層析技術(shù)、電泳技術(shù)、化學(xué)發(fā)光技術(shù)、免疫技術(shù)、生化(酶學(xué))技術(shù)、快速檢測技術(shù)。不同檢測方法的結果存在明顯差異, 建立參考(參比)系統, 從源頭上進(jìn)行管理和控制勢在必行。

IFCC標準化認證

IFCC：國際臨床化學(xué)和檢驗醫學(xué)聯(lián)合會(huì )，成立于1952年，現總部位于意大利的米蘭，是一個(gè)全球性的臨床化學(xué)和實(shí)驗醫學(xué)組織。目前IFCC已發(fā)展了119個(gè)國家和地區會(huì )員，是全球相關(guān)領(lǐng)域最具有影響力組織之一。IFCC通過(guò)與其他國際組織合作制定全球標準，提升實(shí)驗室檢測的準確性、可靠性和可比性。IFCC其重要部門(mén)——科學(xué)部為許多臨床檢驗項目建立參考系統或制備參考物質(zhì)或提供一些項目的溯源程序，糖化血紅蛋白網(wǎng)絡(luò )就是其一。

IFCC的HbA1c檢測程序，成為全球糖化檢測的基準。1995年，IFCC確定了HbA1c標準化工作組，以建立HbA1c檢測的國際統一標準。2004年，ADA、歐洲糖尿病研究學(xué)會(huì )、國際糖尿病學(xué)會(huì )3大國際組織達成共識，確定IFCC作為廠(chǎng)商標準HbA1c檢測系統的全球標準。

Recently, Hotgen Biotech's mono-test chemiluminescence immunoassay analyzer MQ60 Smart for HbA1c detection has received certification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), ensuring the standardization, normalization, and internationalization of its test results. This also signifies that the HbA1c detection results from MQ60 Smart are internationally recognized for their quality and reliability.Glycosylated Hemoglobin (HbA1c) is currently recognized as the gold standard for assessing long-term blood glucose control in diabetic patients and an important indicator for diabetes screening.

Standardization of HbA1c

The detection methods for HbA1c involve chromatography technology, electrophoresis technology, chemiluminescence technology, immunoassay technology, biochemical (enzymatic) technology, and rapid test technology. Significant differences exist in the results from different detection methods, making it imperative to establish a reference (calibration) system for management and control at the source.

IFCC Standardization Certification

IFCC: The International Federation of Clinical Chemistry and Laboratory Medicine, founded in 1952, is now headquartered in Milan, Italy. It is a global organization in the field of clinical chemistry and laboratory medicine. Currently, IFCC has 119 national and regional members and is one of the most influential organizations in the related field worldwide. IFCC collaborates with other international organizations to develop global standards, improving the accuracy, reliability, and comparability of laboratory testing. The Scientific Division of IFCC, an important department, establishes reference systems, prepares reference materials, or provides traceability procedures for many clinical testing items, including the glycosylated hemoglobin network.